Amlodipine besylate sublingual tablet or oral liquid therapy, any combination thereof, or placebo, in adults with major depressive disorder or without comorbid antisocial personality disorder or anxiety disorders who have not previously received SSRI therapy or who have had an acute treatment failure with SSRI.
The subjects were recruited from research population of the University Texas Southwestern Medical Center, Dallas, Texas. Written informed consent was obtained from all study participants, whose information is recorded in the study protocol provided to participants, and their parents responsible surrogate decision makers.
Statistical Methods
Data Analytic Methods
Dependent variables at baseline were depression frequency on the Hamilton Rating Scale for Depression, the Montgomery Grief Questionnaire, and Beck Depression Inventory. Patients randomized to treatment groups received the for 9 weeks, and patients randomized to placebo group received the for 6 weeks. At end of the treatment, participants were required to undergo one final Amlodipine 90 Pills 10mg $119 - $1.32 Per pill assessment of depression (Hamilton Rating Scale for Depression) and one final assessment of anxiety (Beck Depression Inventory). Data from those treated with the SSRI were only analyzed if depressive or anxiety symptoms were present. Data from those randomized to placebo were analyzed if depressive or anxiety symptoms were absent reduced in magnitude. Statistical analyses were performed with SPSS software, version 21.0 (SPSS, Inc., Chicago, Illinois) with a 2-tailed P value of.05.
Multivariable models were used to assess treatment differences in major depression frequency, Beck Inventory scores, Anxiety and Montgomery Grief Questionnaire scores, adjusted for baseline depression frequency and treatment group. The presence of a covariate did not affect the findings. To adjust for baseline anxiety disorder severity, total scores on the Montgomery Grief Questionnaire were calculated and added to the model.
Statistical analysis was performed with SPSS software, version 21.0 (SPSS, Inc., Chicago, Illinois), with a 2-tailed P value of.05.
Data are presented as mean±SD. All analyses were performed with SPSS software, version 21.0 and a 2-tailed P value of.05.
RESULTS
Baseline characteristics of study participants are shown in Table 1. Patients randomized to treatment with sertraline and placebo had similar baseline characteristics. More women (66.8%) than men (61.4%) completed the study. SERT was determined to be more highly expressed in the brains of patients randomized to treatment with sertraline than in those randomized to placebo. The P value for difference in sertraline versus placebo expression at baseline was not statistically significant at the.05 level. median baseline sertraline concentration was 0.5 micrograms per milliliter, and the median placebo concentration was 3.5 micrograms per milliliter. No sertraline users and placebo had an average initial sertraline concentration between 0.5 and 3.5 micrograms per milliliter (Table 1).
Primary Outcome in SERT Validation
The P value of difference between treatment groups for change in response was 2.27 times greater for sertraline treatment at the 2-month follow-up than control treatment (P<.01). These findings are consistent with previous observations that sertraline was less effective than placebo at preventing relapse in a double-blind and placebo-controlled trial in patients with major depression.25-27 This was also demonstrated in a nonrandomized trial that found similar results (ie, treatment differences, but with more participants treated sertraline),28 which suggested that the difference in treatment response occurred through sertraline alone or the interaction between sertraline and another antidepressant. The differences in magnitude of sertraline response at the 1- and 2-month follow-ups were not statistically different as a group (P=.29 for the 1-month and P=.40 2-month changes, respectively).
Secondary Outcomes
Change in severity of anxiety was assessed between the 2-month and 6-month intervals. For the whole study population, mean change in severity of anxiety was 21.9±2.2 on the Montgomery Grief Questionnaire. For patients who took sertraline on days 1, 2, and 7, the mean change from baseline to 1-month follow-up was 1.9±1.5, the mean change to 2-month follow-up was 4.0±2.7, and the mean change to 6-month follow-up was 8.0±5.3. The results were similar when analysis was restricted to patients who received sertraline between days 1 and 2, or to patients who received sertraline on days 1, 2, and 7 only, or both (Figures 1 and 2).
All patients who received sert.
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